BEUDAMED
    FDA Enforcement Class II Terminated

    MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.

    Recall: Z-0719-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0719-2018
    Event ID
    78973
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medistim Asa
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    March 7, 2018
    Initiation Date
    April 25, 2017
    Classification Date
    February 26, 2018
    Termination Date
    May 3, 2024
    Address
    Okernveien 94, N/A, Oslo, N/A, N/A, Norway

    Description

    MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.

    Reason

    A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.

    Code Info

    UDI: 7070554101198 Serial#: 1170 and 1294

    Distribution

    Distributed to New York.

    Quantity

    2